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Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepines in First-Episode Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
German Research Network On Schizophrenia
Janssen-Cilag Ltd.
University Hospital, Bonn
Humboldt-Universität zu Berlin
Ludwig-Maximilians - University of Munich
University of Göttingen
University of Cologne
Mainz University
University Hospital Tuebingen
Universität Duisburg-Essen
University of Mannheim
University of Jena
Martin-Luther-Universität Halle-Wittenberg
RWTH Aachen University
University of Wuerzburg
Information provided by:
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00159133
First received: September 7, 2005
Last updated: January 28, 2008
Last verified: January 2008
History of Changes
  Purpose

Prodrome based early intervention with an antipsychotic drug vs. benzodiazepine was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment, the other one after stepwise drug discontinuation.


Condition Intervention Phase
Schizophrenia
Psychoses
 Drug: antipsychotics vs. Lorazepam (Drugs)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepine in Patients With First-Episode Schizophrenia After One Year Maintenance Treatment Under Further Maintenance Treatment vs. Stepwise Discontinued Drugs

Resource links provided by NLM:

Drug Information available for: Lorazepam
U.S. FDA Resources

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • relapse rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • psychopathology [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • social and cognitive functioning [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • side-effects [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • drop-out [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 71
Study Start Date: November 2001
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Early intervention with benzodiazepines in case of prodromal symptoms of an impending relapse
 Drug: antipsychotics vs. Lorazepam (Drugs)
Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;
Active Comparator: 2
Early intervention with antipsychotics in case of prodromal symptoms of an impending relapse
 Drug: antipsychotics vs. Lorazepam (Drugs)
Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;

Detailed Description:

In case of early signs of a relapse prodrome based early intervention with an antipsychotic drug (Haloperidol, Risperidone and other) vs. benzodiazepine (Lorazepam) was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment (Haloperidol, Risperidone and other) , the other one after stepwise drug discontinuation.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First-episode in schizophrenia (according ICD-10 F20)
  • Age between 18 and 55
  • Informed consent
  • One year neuroleptic maintenance treatment

Exclusion Criteria:

  • Residence outside of the catchment area
  • Legal reasons
  • Insufficient knowledge of the german language
  • Substance abuse or addiction
  • Pregnancy
  • Serious physical illness
  • Organic brain disease
  • Contraindication to neuroleptic treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159133

Locations
Germany
German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40629
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
German Federal Ministry of Education and Research
German Research Network On Schizophrenia
Janssen-Cilag Ltd.
University Hospital, Bonn
Humboldt-Universität zu Berlin
Ludwig-Maximilians - University of Munich
University of Göttingen
University of Cologne
Mainz University
University Hospital Tuebingen
Universität Duisburg-Essen
University of Mannheim
University of Jena
Martin-Luther-Universität Halle-Wittenberg
RWTH Aachen University
University of Wuerzburg
Investigators
Study Chair: Wolfgang Gaebel, Professor Department of Psychiatry and Psychotherapy, University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf
  More Information

Additional Information:
Click here for more information about this study: Pharmacological long-term treatment strategies for relapse prevention in first episode schizophrenia  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00159133     History of Changes
Other Study ID Numbers: 01GI 9932 - P 2.2.2.2
Study First Received: September 7, 2005
Last Updated: January 28, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heinrich-Heine University, Duesseldorf:
Schizophrenia
first episode
prodrome based early intervention
 antipsychotics - benzodiazepine
maintenance treatment
drug discontinuation

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Lorazepam
Antipsychotic Agents
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
 Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 19, 2013